510(k) Report

510(k) · Cleared

Cleared

Trident Porous Titanium Acetabular Component

K010170510(k) TraditionalCleared Apr 18, 200190-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Apr 18, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 297 later devices descend from it.

Decided
Apr 18, 2001
Review
90 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

297 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2008: 7 descendants cleared2016: 10 descendants cleared2015: 10 descendants cleared2012: 17 descendants cleared2014: 8 descendants cleared2011: 14 descendants cleared2004: 1 descendant cleared2001: 1 descendant cleared2005: 1 descendant cleared2019: 20 descendants cleared2017: 19 descendants cleared2007: 2 descendants cleared2013: 16 descendants cleared2023: 21 descendants cleared2025: 25 descendants cleared2020: 16 descendants cleared2021: 25 descendants cleared2018: 14 descendants cleared2022: 22 descendants cleared2006: 5 descendants cleared2009: 5 descendants cleared2026: 18 descendants cleared2024: 15 descendants cleared2010: 5 descendants cleared200020052010201520202025
  1. This deviceK010170 Trident Porous Titanium Acetabular ComponentHowmedica Osteonics Corp. · 2001
  2. Descendant · cites it directly · 216 of its ownK013475 Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp. · 2001
  3. Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  4. Descendant · 3 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
  5. Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  6. Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008

Showing 5 of 297 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12005: 12006: 52007: 22008: 72009: 52010: 52011: 142012: 172013: 162014: 82015: 102016: 102017: 192018: 142019: 202020: 162021: 252022: 222023: 212024: 152025: 252026: 18
2001high 25 (2021) · low 0 (2002)2026

Most influential descendants

Showing 5 of 297 · See all
  • K013475Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp. · 2001 · cites it directly216descendants
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
  • K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 3 generations on90descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
  • K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010170Trident Porous Titanium Acetabular ComponentHowmedica Osteonics Corp.2001—
+1K013475Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp.2001—
+2K042344Excia Total Hip SystemAesculap, Inc.200510
+3K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.2006—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200510
200650
200720
200870
200950
201050
2011140
2012170
2013160
201480
2015100
2016100
2017190
2018140
2019200
2020160
2021250
2022220
2023210
2024150
2025250
2026180
FIG. 1 — Lineage of K010170, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (297)

See all 297

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013475Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp.2001216
K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861
K112802Pipeline Total Hip SystemPipeline Orthopedics201253
K103233Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp.201152
K040412Trident T Acetabular ShellsStryker Orthopaedics200423
K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics201521
K142462Restoration Anatomic ShellStryker Orthopaedics201419
K151264Restoration Anatomic ShellStryker Orthopaedics201518
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics201617

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K013475 (Howmedica Osteonics Corp., 2001) has gone furthest, with 216 descendants of its own.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K010170 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010170: Trident Porous Titanium Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010170

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026